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NCT00311246 · ClinicalTrials.gov registry record · Phase 2
Trial of Adalimumab in Progressive Sarcoidosis
A Phase 2 study, sponsored by University of Chicago.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT00311246 is a Phase 2 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 11 participants.
The verdict
NCT00311246, a Phase 2 study, was terminated before completion, sponsored by University of Chicago.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
Sarcoidosis is a rare disease that can affect any organ in the body. It is characterized by the buildup of immune-system (fights off infection in the body) cells in organs. These cells form small groups called granulomas, which lead to inflammation of the surrounding tissue. Sarcoidosis most commonly affects the lung and the lymph nodes (part of the immune system). The signs usually include shortness of breath, fever, dry cough, and chest pain. Other signs in many patients can include redness and painful lumps on the skin, reduced eyesight, joint pain, and rarely, nervous system damage. Sarcoidosis commonly affects young and middle-aged adults. There are no approved therapies for the treatment of sarcoidosis. Corticosteroid (steroid hormone) therapy is considered the standard treatment. Only limited benefit has been shown when using corticosteroid therapy to ease lung symptoms or improve lung function in patients with sarcoidosis. Also, the effects of other therapies (for example: methotrexate, cyclophosphamide, anti-malarial drugs, thalidomide) and other immunosuppressants (drugs that suppress a body's natural defense system \[immune system\]) which have been used in a small number of patients are not well known and can cause long term problems. The drug used in this study is called adalimumab. Adalimumab is FDA (Food and Drug Administration) approved for patients with moderately to severely active rheumatoid arthritis. However, adalimumab is not approved for the treatment of sarcoidosis. Adalimumab is experimental in this study. The purpose of this study is to evaluate the safety and effectiveness of adalimumab in the treatment of patients with sarcoidosis with pulmonary (lung) involvement who show symptoms of the disease even though they are currently being treated with medication.
Interventions
- DRUG Adalimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2006-04 |
| Est. Completion | 2008-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00311246
The ClinicalTrials.gov registry entry for NCT00311246 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Adalimumab is the first listed.
NCT00311246 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00311246 about?
NCT00311246 is a clinical study titled "Trial of Adalimumab in Progressive Sarcoidosis". Sarcoidosis is a rare disease that can affect any organ in the body. It is characterized by the buildup of immune-system (fights off infection in the body) cells in organs. These cells form small groups called granulomas, which lead to inflammation of the surrounding tissue. Sarcoidosis most commonl...
What is the current status of trial NCT00311246?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2006-04. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00311246?
The interventions under investigation include: Adalimumab (DRUG).
Who is sponsoring clinical trial NCT00311246?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
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